BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1725001 · Received June 10, 2010

    Report

    Report Number
    MW5016336
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED MEDTRONIC GLUCOSE SENSORS FROM (B) (4). THESE PRODUCTS CAN BE UNRELIABLE AND THEY HAVE A SHELF LIFE OF LESS THAN 6 MONTHS. I HAVE COMPLAINED ABOUT THE DIFFICULTIES AND HAVE BEEN GIVEN SEVERAL "HINTS" ON HOW TO INSERT, SEAL, CALIBRATE OR IN GENERAL CARE FOR THESE PRODUCTS. NONE OF THESE DIFFICULTIES WERE EXPLAINED WHEN I PURCHASED THE PRODUCT AND I HAD 3 BOXES (B) (6) EXPIRE BECAUSE I WAS NEVER INFORMED THAT THERE WAS AN EXPIRATION DATE. EVENT WHEN I WAS TOLD WHERE THE DATE WAS LOCATED ON THE BOX, I STILL DIDN'T REALIZE THAT IT WAS A DATE AND NOT A CODE. THE SENSORS WORK WITH A TRANSMITTER THAT HAS A COST OF APPROX (B) (6). THERE IS A 6 MONTH WARRANTY ON THIS PRODUCT AND I WAS AWARE OF THAT. WHEN I STARTED TO HAVE TROUBLE WITH THE SENSOR, I WAS TOLD THAT THE TRANSMITTERS ARE ONLY EXPECTED TO LAST UP TO 1 YEAR. I FIND THAT THE MARKETING TECHNIQUES WERE SNEAKY AND EVASIVE. IN ADDITION, I USED THE QUICKSET CANNULA INFUSION SET AND I HAVE LOST THE INFUSION SITE 5 TIMES IN THE PAST YEAR AND I HAVE NEEDED TO REMOVE 4 OR 5 OF THE INFUSION SETS BECAUSE, I WAS HAVING HIGH BLOOD SUGAR READINGS. WHEN REMOVED, I NOTICED THAT THE CANNULAS WERE BENT. I HAVE HAD PROBLEMS IN THE PAST WITH THE INFUSION SETS NOT BEING THREADED PROPERLY AT THE CAP AND THE RESERVOIRS NOT FITTING INTO THE PUMP OR INFUSION SET PROPERLY. I AM TIRED OF COMPLAINING. I SIMPLY WANT THESE PRODUCTS TO WORK WITHOUT STRUGGLING. DATES OF USE: #1 - (B) (6) 2009 - (B) (6) 2010. # 2 - (B) (6) 2009 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOF-SENSOR, GLUCOSE SENSORS MDS MEDTRONIC MMT-7002N C050
    2 MEDTRONIC QUICK SET PARADIGM, QUICKSET CANNULA INFUSION SET FPA MEDTRONIC MMT397 9200448

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other